酶联免疫四项检测结果灰区与窗口期感染的关系

Relationship between grey area of 4-index detection results by ELISA and window period infection

目的探讨酶联免疫吸附试验检测志愿无偿献血标本酶联免疫(简称酶免)四项(乙型肝炎表面抗原、丙型肝炎病毒抗体、人类免疫缺陷病毒抗体及梅毒螺旋体抗体)检测结果灰区与窗口期感染的相关性。方法收集2012年1月至2013年9月泸州地区志愿无偿献血者的献血标本58 152例,以灰区范围检测值/临界值(S/CO)在0.6~1.0的献血者为研究对象,该人群进一步献血的检验结果为确证试验结果。结果 2 342例灰区研究对象半年后在血液检测管理系统中查询,有再献血记录的597例,其中合格331例,占55.44%,不合格266例,占44.56%。以合格的331例为对照组,不合格的266例为观察组,2016年12月31日查询,对照组酶免四项检测结果2例阳性,观察组9例阳性,差异有统计学意义(χ~2=8.83,P<0.05)。结论酶免四项检测结果灰区范围的血液存在窗口期感染的风险,实验室设置合适的灰区范围是保证安全输血的重要措施,也是防止发生窗口期感染的重要手段之一。

Objective To investigating the relationship between the gray area of four-index detection results（HBsAg,anti-HCV antibody,anti-HIV antibody and anti-TP antibody）by enzyme-linked immunosorbent assay（ELISA）and the window period infection in voluntary blood donors.Methods A total of 58 152 blood samples from voluntary blood donors in Luzhou area from January 2012 to September 2013 were collected.The donors with the grey area of S/CO 0.6-1.0 served as the research subjects.The further donation detection results were the confirmatory test.Results A total of 2 342 grey area research subjects were inquired in the blood detection and management system after half a year.Among 597 cases of again blood donation,331 cases were qualified,accounting for 55.44%,unqualified blood was in 266 cases,accounting for 44.56%;with 331 qualified cases as the control group and266 unqualified cases as the observation group,the inquiring on December 31,2016 showed that in ELISA 4-item detection,2 cases in the control group were positive and 9 cases in the observation group were positive,the difference was statistically significant（χ~2=8.83,P0.05）.Conclusion The blood in the grey area of the 4-index detection results by ELISA has a risk of window period infection,and setting aappropriate gray area range in laboratory is an important measure to ensure the safety of blood transfusion,and also one of the most significant means to prevent window period infection.